IBI3042 Study in Healthy Participants and Overweight or Obese Participants

Phase 1RecruitingNCT07793019

Innovent Biologics (Suzhou) Co. Ltd.104 enrolled

Overview

This is a Phase 1 study of IBI3042, an investigational oral medicine being developed as a potential treatment for overweight and obesity. The study has two parts. Part A will evaluate single doses of IBI3042 in healthy adults. Part B will evaluate repeated doses for 13 weeks in adults with overweight or obesity. The main goal is to assess the safety and tolerability of IBI3042. The study will also evaluate how IBI3042 is processed in the body and explore its effects on body weight and other metabolic measures. Some participants will receive placebo, and some Part B groups will also receive orforglipron for comparison.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

104

Conditions

Overweight Healthy Participants Obesity

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Aged 18 to 55 years, inclusive. * For Part A: BMI ≥20 and \<30 kg/m\^2 and body weight ≥50 kg. * For Part B: BMI ≥24 and ≤40 kg/m\^2, with stable body weight during the 3 months prior to screening. * Female participants of childbearing potential and male participants with female partners of childbearing potential must agree to use highly effective contraception during the study and for 90 days after the last dose. * Able and willing to comply with study procedures and voluntarily provide written informed consent. Exclusion Criteria: * Known or suspected hypersensitivity to any component of the study drug or to GLP-1 receptor agonists. * History of diabetes or abnormal glycemic parameters at screening. * Personal or family history of thyroid C-cell carcinoma or multiple endocrine neoplasia syndrome type 2 (MEN 2A or 2B), or calcitonin ≥20 ng/L at screening. * History of acute or chronic pancreatitis, or clinically significant pancreatic enzyme elevation at screening. * Use of medications that may significantly affect gastrointestinal motility, appetite, or drug absorption within 3 months prior to screening. * Clinically significant hematologic, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurologic disease that may increase study-related risk or interfere with study assessments. * Clinically significant abnormalities in physical examination or laboratory tests at screening. * History of malignancy within 5 years, except for basal cell or squamous cell skin cancer. * Use of prescription or over-the-counter medications, dietary supplements, or herbal medicines within 2 weeks or 5 half-lives prior to screening, except as permitted by the protocol. * Participation in another drug or medical device clinical study within 3 months prior to screening or within 5 half-lives of the investigational drug, as applicable. * Any other condition that, in the investigator's opinion, makes the participant unsuitable for participation in the study.

Outcomes

Primary Outcomes

Number of Participants With Adverse Events (Part A)

Number of subjects with Adverse Event

Time frame: through study completion, an average of 29 days

Number of Participants With Abnormal Physical Examination Findings (Part A)

Number of participants with at least one clinically significant abnormal finding in physical examination. Physical examination includes general appearance, respiratory tract, cardiovascular, abdominal, skin, head and neck (ear, eye, nose, throat) , lymph node, thyroid, musculoskeletal (spine and extremities), and neurological assessments. Anogenital examination may be omitted as permitted per protocol.

Time frame: through study completion, an average of 29 days

Number of Participants With Clinically Significant Abnormal Vital Signs (Part A)

Number of participants with at least one clinically significant abnormal vital sign，including body temperature, pulse, respiratory rate and blood pressure.

Time frame: through study completion, an average of 29 day

Number of Participants With Clinically Significant Abnormal Laboratory Tests (Part A)

Number of participants with at least one clinically significant abnormal laboratory finding. Laboratory tests including blood routine, blood Biochemistry (including blood lipids), coagulation routine, urine routine, calcitonin, glycated hemoglobin (HbA1c), infection-related immunology tests, thyroid function tests, pregnancy test, serum follicle-stimulating hormone (FSH) .

Time frame: through study completion, an average of 29 days

Number of Participants With Clinically Significant Abnormal Twelve?Lead Electrocardiogram Readings (Part A)

Number of participants with at least one clinically significant abnormal finding on resting 12?lead electrocardiogram (ECG). Participants shall lie supine for at least 5 minutes prior to ECG acquisition and remain supine during ECG recording. Evaluated ECG parameters include RR interval, PR interval, heart rate, QT interval, and QTcF (QTcF=QT/RR\^0.33).

Time frame: through study completion,an average of 29 days

Number of Participants With Adverse Events (Part B)

Number of subjects with Adverse Event

Time frame: through study completion, an average of 113 days

Number of Participants With Abnormal Physical Examination Findings (Part B)

Number of participants with at least one clinically significant abnormal finding in physical examination. Physical examination includes general appearance, respiratory tract, cardiovascular, abdominal, skin, head and neck (ear, eye, nose, throat), lymph node, thyroid, musculoskeletal (spine and extremities), and neurological assessments. Anogenital examination may be omitted as permitted per protocol.

Time frame: through study completion, an average of 113 days

Number of Participants With Clinically Significant Abnormal Vital Signs (Part B)

Number of participants with at least one clinically significant abnormal vital sign, including body temperature, pulse, respiratory rate and blood pressure.

Time frame: through study completion, an average of 113 days

Number of Participants With Clinically Significant Abnormal Laboratory Tests (Part B)

Number of participants with at least one clinically significant abnormal laboratory finding. Laboratory tests include blood routine, blood biochemistry (including blood lipids), coagulation routine, urine routine, calcitonin, glycated hemoglobin (HbA1c), infection?related immunology tests, thyroid function tests, pregnancy test, serum follicle?stimulating hormone (FSH).

Time frame: through study completion, an average of 113 days

Number of Participants With Clinically Significant Abnormal Twelve?Lead Electrocardiogram Readings (Part B)

Time frame: through study completion, an average of 113 days

Secondary Outcomes

Area Under the Plasma Concentration?Time Curve (AUC) (Part A)

Time frame: through study completion,an average of 29 days

Peak Plasma Concentration (Cmax) (Part A)

Time frame: through study completion,an average of 29 days

Time to Reach Peak Plasma Concentration (Tmax) (Part A)

Time frame: through study completion,an average of 29 days

Apparent Clearance (CL/F) (Part A)

Time frame: through study completion,an average of 29 days

Apparent Volume of Distribution (Vz/F) (Part A)

Time frame: through study completion,an average of 29 days

Terminal Half-Life (T1/2) (Part A)

Time frame: through study completion,an average of 29 days

Area Under the Plasma Concentration?Time Curve (AUC) (Part B)

Time frame: through study completion, an average of 113 days

Peak Plasma Concentration (Cmax) (Part B)

Time frame: through study completion, an average of 113 days

Time to Reach Peak Plasma Concentration (Tmax) (Part B)

Time frame: through study completion, an average of 113 days

Apparent Clearance (CL/F) (Part B)

Time frame: through study completion, an average of 113 days

Apparent Volume of Distribution (Vz/F) (Part B)

Time frame: through study completion, an average of 113 days

Terminal Half-Life (T1/2) (Part B)

IBI3042 Study in Healthy Participants and Overweight or Obese Participants

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts